There are two brands of thyroxine available in Australia – Oroxine and Eutroxsig – both manufactured by Sigma Pharmaceuticals. If you have had an Oroxine or Eutroxsig prescription filled since June, you will have discovered that these products now require refrigeration at all times. Up until now, these products could be kept in a cool, dry place below 30oC and protected from light. Oroxine and Eutroxsig are still the same; they are still manufactured in exactly the same way using exactly the same ingredients. The only thing that has changed is the storage requirement.

In June 2003 Sigma was instructed by the Therapeutic Goods Administration (TGA) to reduce the shelf lives of Oroxine and Eutroxsig from 24 months to 12 months (with refrigeration).

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Thyroid Australia is concerned that this change is yet another thing that will make it more difficult for patients to consistently take their required dose every day. We view it as a retrograde step in the treatment of hypothyroidism in Australia. It seems likely that the change to refrigeration could have a negative impact on compliance (the consistency and accuracy with which patients follows prescribed treatment regime), as well as being an additional hassle for hypothyroid patients.

We have met with the Commercial Manager of Oroxine and Eutroxsig from Sigma since the introduction of refrigeration. Sigma is working with the TGA to improve the storage conditions for Oroxine and Eutroxsig, and is aware of the problems refrigeration is causing for patients.

A possible method to reduce the inconvenience surrounding the refrigeration of Oroxine and Eutroxsig is ...

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This issue highlights the importance of not using Oroxine or Eutroxsig that is past its expiry date.

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Thyroid Australia will continue lobbying for intermediate doses in Australia and will be seeking to have storage requirements and shelf lives restored to previous standards.

If your doctor prescribes a dose of Oroxine or Eutroxsig other than the available doses of 50, 100 or 200 micrograms (mcg), it can be difficult to achieve this dose. We have prepared a fact sheet on how to obtain intermediate doses (ie. 135mcg) by taking different doses on different days. This can be accessed via the Downloads page of our website (www.thyroid.org.au).

Note: Eutroxsig is exactly the same as Oroxine – tablets in Eutroxsig bottles are identical to Oroxine tablets (and are even marked ‘Oroxine’). The only difference is that Eutroxsig is cheaper.

Bronwyn Stevens
is a final year Behavioural Neuroscience student at Monash University and Thyroid Australia’s Volunteer Co-ordinator.

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